Recurrent Clostridium Difficile InfectionNCT05826418
Dietary Optimization of Microbiome Recovery Following Fecal Microbiota Transplantation
A study testing MEND diet and mNICE diet in people with Recurrent Clostridium Difficile Infection and Fecal Microbiota Transplant, run by University of Minnesota at 1 site in United States.
Trial summary
Recurrent Clostridioides difficle infection (rCDI) is a very significant problem in its own right and current fecal microbiota transplant (FMT) -based therapeutics will benefit from their optimization for this indication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Clostridium Difficile Infection, Fecal Microbiota Transplant
- What is being tested?
- MEND diet and mNICE diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 12 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- Clinical plans to undergo FMT therapy for treatment of rCDI (≥ 2 CDI recurrences following the initial episode within 1 year without contraindications to the treatment)
- Ability to comply with study requirements
- Age at least 18 years old
Who cannot join
- Underlying IBD
- History of stomach surgery or bowel resection
- Anticipated antibiotic exposure during the study period
- Advanced liver disease
- Ongoing alcohol or drug abuse
- Pregnancy
- Any reason felt by the investigator to complicate the feasibility of participation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
Recurrent Clostridioides difficle infection (rCDI) is a very significant problem in its own right and current fecal microbiota transplant (FMT) -based therapeutics will benefit from their optimization for this indication. It is likely that appropriate nutritional support coupled with microbiota-based drugs will yield superior clinical outcomes. However, both diet and gut microbiome are very complex. This project, which is based on a wealth of FMT experience, both clinical and investigational, over the past decade along with the novel techniques developed to identify dietary patterns and food groups that explain the most variation in gut microbiome, offers an ideal platform for performing systematic research in nutritional support that promotes gut microbiota health. The purpose is to Generate preliminary data with regards to tolerability of the Microbiota enhancing and nourishing diet (MEND) and its effects on the fecal microbiota in rCDI patients following FMT with the goal of developing larger clinical trials aimed to optimize post-FMT dietary management.
- Being tested
- MEND diet, mNICE diet
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEND dietDietary supplement
Participants will be asked to adhere to their randomized MEND diet for 4 weeks and FMT. The FMT being offered is part of standard clinical care, as recommended by current practice guidelines. They will complete bi-weekly IBS symptom score questionnaires and stool samples collection from consent to week 4. Following the 4-week intervention period patients will not be asked to adhere to a study diet.
mNICE dietDietary supplement
Participants will be asked to adhere to their randomized mNICEdiet for 4 weeks and FMT. The FMT being offered is part of standard clinical care, as recommended by current practice guidelines. They will complete bi-weekly IBS symptom score questionnaires and stool samples collection from consent to week 4. Following the 4-week intervention period patients will not be asked to adhere to a study diet.
| Study group | Role | What they receive |
|---|---|---|
| MEND diet | Experimental | patients being treated with FMT Receives: Dietary Supplement: MEND diet |
| mNICE (modified NICE) diet | Active comparator | patients being treated with FMT Receives: Dietary Supplement: mNICE diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant acceptance of the diet
Diet acceptability questionnaire: Includes 7 questions each with minimum and maximum values (1 and 7) and higher scores mean better outcomes.
Measured: 4 weeks
Participant compliance with study procedures
24-hr dietary recalls will be used to assure adherence with the study diet
Measured: intervention to 4 weeks
Secondary outcomes (9)
Bacterial diversity
Shannon diversity index
Measured: 1 week
Bacterial diversity
Shannon diversity index
Measured: 4 weeks
Bacterial diversity
Shannon diversity index
Measured: 3 months
Similarity to donor bacterial composition
Using SourceTracker: which uses modeling based on 16S rDNA sequencing, is the measurement tool used to assess the measure
Measured: 1 week
Similarity to donor bacterial composition
Using SourceTracker: which uses modeling based on 16S rDNA sequencing, is the measurement tool used to assess the measure
Measured: 4 weeks
Similarity to donor bacterial composition
Using SourceTracker
Measured: 3 months
Bacterial composition
Relative abundance of specific bacteria previously documented to be predictive of successful FMT outcomes with respect to CDI recurrence
Measured: 1 week
Bacterial composition
Relative abundance of specific bacteria previously documented to be predictive of successful FMT outcomes with respect to CDI recurrence
Measured: 4 weeks
Bacterial composition
Relative abundance of specific bacteria previously documented to be predictive of successful FMT outcomes with respect to CDI recurrence
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start1 May 2023
- Primary completion12 Mar 2024
- Study completion12 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Clostridium Difficile InfectionStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Khoruts, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826418
- Sponsor's protocol ID
- rCDI
- Status last verified
- Aug 2025
- First submitted
- 17 Mar 2023
- Last updated
- 12 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Optimization of Microbiome Recovery Following Fecal Microbiota Transplantation
- ClinicalTrials.gov ID
- NCT05826418
- Acronym / sponsor ID
- rCDI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 12 Mar 2024 (actual)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Recurrent Clostridioides difficle infection (rCDI) is a very significant problem in its own right and current fecal microbiota transplant (FMT) -based therapeutics will benefit from their optimization for this indication. It is likely that appropriate nutritional support coupled with microbiota-based drugs will yield superior clinical outcomes. However, both diet and gut microbiome are very complex. This project, which is based on a wealth of FMT experience, both clinical and investigational, over the past decade along with the novel techniques developed to identify dietary patterns and food groups that explain the most variation in gut microbiome, offers an ideal platform for performing systematic research in nutritional support that promotes gut microbiota health. The purpose is to Generate preliminary data with regards to tolerability of the Microbiota enhancing and nourishing diet (MEND) and its effects on the fecal microbiota in rCDI patients following FMT with the goal of developing larger clinical trials aimed to optimize post-FMT dietary management.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MEND diet | Experimental | Dietary Supplement: MEND dietpatients being treated with FMT |
| mNICE (modified NICE) diet | Active comparator | Dietary Supplement: mNICE dietpatients being treated with FMT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed consent
- Clinical plans to undergo FMT therapy for treatment of rCDI (≥ 2 CDI recurrences following the initial episode within 1 year without contraindications to the treatment)
- Ability to comply with study requirements
- Age at least 18 years old
Key exclusion criteria (7 listed)
- Underlying IBD
- History of stomach surgery or bowel resection
- Anticipated antibiotic exposure during the study period
- Advanced liver disease
- Ongoing alcohol or drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEND dietParticipants will be asked to adhere to their randomized MEND diet for 4 weeks and FMT. The FMT being offered is part of standard clinical care, as recommended by current practice guidelines. They will complete bi-weekly IBS symptom score questionnaires and stool samples collection from consent to week 4. Following the 4-week intervention period patients will not be asked to adhere to a study diet. | Dietary supplement | MEND diet |
| mNICE dietParticipants will be asked to adhere to their randomized mNICEdiet for 4 weeks and FMT. The FMT being offered is part of standard clinical care, as recommended by current practice guidelines. They will complete bi-weekly IBS symptom score questionnaires and stool samples collection from consent to week 4. Following the 4-week intervention period patients will not be asked to adhere to a study diet. | Dietary supplement | mNICE (modified NICE) diet |
Primary outcome
Participant acceptance of the diet
Time frame: 4 weeks
Diet acceptability questionnaire: Includes 7 questions each with minimum and maximum values (1 and 7) and higher scores mean better outcomes.
Participant compliance with study procedures
Time frame: intervention to 4 weeks
24-hr dietary recalls will be used to assure adherence with the study diet
9 secondary outcomes
Bacterial diversity
Time frame: 1 week
Bacterial diversity
Time frame: 4 weeks
Bacterial diversity
Time frame: 3 months
Similarity to donor bacterial composition
Time frame: 1 week
Similarity to donor bacterial composition
Time frame: 4 weeks
Similarity to donor bacterial composition
Time frame: 3 months
Bacterial composition
Time frame: 1 week
Bacterial composition
Time frame: 4 weeks
Bacterial composition
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Khoruts, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEND diet and mNICE diet in people with Recurrent Clostridium Difficile Infection and Fecal Microbiota Transplant, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant acceptance of the diet (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.